Study of Nab-paclitaxel in Sensitive and Refractory Relapsed SCLC

NCT03219762 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-07-26

No results posted yet for this study

Summary

Evaluate the activity and safety of Nab-paclitaxel in patients with sensitive or refractory SCLC who relapsed after cisplatin or carboplatin and etoposide first-line chemotherapy.

Conditions

Interventions

DRUG

Nabpaclitaxel

Chemotherapy will be continued until a maximum of 6 courses or progressive disease or intolerable toxicity or patient refusal. In patients with confirmed and prolonged disease response, clinical benefit and good tolerance to study drug treatment, the investigators can evaluate to continue therapy beyond 6th cycle, after discussion with Principal Investigator (PI) of the study

Sponsors & Collaborators

  • Temas srl

    collaborator UNKNOWN
  • Clirest s.r.l.

    collaborator OTHER
  • Mipharm S.p.A.

    collaborator UNKNOWN
  • Istituto Toscano Tumori

    collaborator OTHER
  • Gruppo Oncologico Italiano di Ricerca Clinica

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-07
Primary Completion
2019-01-31
Completion
2019-01-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03219762 on ClinicalTrials.gov